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  • ASTM F 3207 : 2017

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    Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-06-2017

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.02, 2017 Defines the single-level rabbit posterolateral, or intertransverse, lumbar spine fusion model was developed and reported on by Dr. Scott Boden, et. al. (Emory Spine Center for Orthopedics) and the model has been proposed as a nonclinical model which may be used to replicate clinicallyrelevant fusion rates for iliac crest autograft in the posterolateral spine.

    Scope - (Show below) - (Hide below)

    1.1Historically, the single-level rabbit posterolateral, or intertransverse, lumbar spine fusion model was developed and reported on by Dr. Scott Boden, et. al. (Emory Spine Center for Orthopedics) and the model has been proposed as a non-clinical model which may be used to replicate clinically-relevant fusion rates for iliac crest autograft in the posterolateral spine (1, 2).2 This model is used routinely in submissions to regulatory bodies for the purpose of evaluating the potential efficacy of bone void filler materials as compared to other materials or iliac crest autograft to effect spinal posterolateral fusion. The use of this standard’s recommendations as part of a regulatory submission does not provide any guarantee of regulatory clearance and should be considered as a part of the data provided for regulatory submission.

    1.2This guide covers general guidelines to evaluate the effectiveness of products intended to cause and/or promote bone formation in the lumbar intertransverse process spinal fusion model in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents). It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of bone void fillers and/or autograft extender products in vivo. The purpose of this guide is not to exclude other established methods.

    1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.4This standard does not purport to address all of the safety concerns, if any, associated with the use of bone void fillers. It is the responsibility of the user of this standard to establish appropriate safety and health practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the bone-forming/promoting capabilities of the product.

    1.5This standard does not purport to address the requirements under 21 CFR Part 58 concerning Good Laboratory Practices or international standard counterpart OECD Principles of Good Laboratory Practice (GLP). It is the responsibility of the sponsor of the study to understand the requirements for conduct of animal studies whereby the data may be used to support premarket applications, including requirements for personnel, protocol content, record retention and animal husbandry.

    1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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    Committee F 04
    Document Type Guide
    Publisher American Society for Testing and Materials
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM E 122 : 2017 : REDLINE Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
    ASTM E 1488 : 2009 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
    ASTM E 1488 : 2002 : EDT 1 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
    ASTM F 2884 : 2012 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion (Withdrawn 2021)
    ASTM F 2884 : 2021 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
    ASTM F 2529 : 2013 : R2021 Standard Guide for  in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
    ASTM E 122 : 2017 : R2022 Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
    ASTM E 122 : 2017 Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
    ASTM E 1402 : 2013 Standard Guide for Sampling Design
    ASTM E 1488 : 2008 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
    ASTM E 1402 : 2013 : R2018 Standard Guide for Sampling Design
    ASTM E 1402 : 1999 Standard Terminology Relating to Sampling
    ASTM E 1402 : 2008 : EDT 1 Standard Guide for Sampling Design
    ASTM E 1488 : 1996 Standard Guide for Statistical Procedures to Use in Developing and Applying ASTM Test Methods
    ASTM E 1488 : 2008 : REV A Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
    CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
    ASTM F 2529 : 2013 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
    ASTM E 1488 : 2012 : R2018 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
    ASTM E 1488 : 2012 : EDT 1 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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